Cleared Traditional

MAXINSIGHT

K070358 · Eemagine Medical Imaging Solutions GmbH · Neurology

Jul 2007

Decision

173d

Days

Class 2

Risk

About This 510(k) Submission

K070358 is an FDA 510(k) clearance for the MAXINSIGHT, a Source Localization Software For Electroencephalograph Or Magnetoencephalograph (Class II — Special Controls, product code OLX), submitted by Eemagine Medical Imaging Solutions GmbH (Deer Field, US). The FDA issued a Cleared decision on July 30, 2007, 173 days after receiving the submission on February 7, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K070358 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2007
Decision Date	July 30, 2007
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OLX — Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization